DALLAS — Oct. 6, 2010 — A set of proteins found in blood serum shows promise as a sensitive and accurate way to diagnose Alzheimer’s disease, researchers at UT Southwestern Medical Center have found as part of a statewide study.
An analysis of the proteins, plus a clinical exam, proved 94 percent accurate in detecting suspected Alzheimer’s and 84 percent accurate in ruling it out in people without the disease, the researchers said.
“This research uses a novel technology that makes it possible to analyze several biomarkers in a single blood sample in a cost-effective way,” said Dr. Ramón Díaz-Arrastia, professor of neurology at UT Southwestern and senior author of the study which was published in the September issue of the Archives of Neurology.
Researchers have been seeking a simple blood test for Alzheimer’s for years, Dr. Díaz-Arrastia said, but no single substance, or “biomarker,” has been shown to be useful. Such a test, he said, would be comparable in principle to measuring blood cholesterol as a biomarker of cardiovascular disease.
Alzheimer’s disease is an incurable degenerative brain disease, which currently afflicts about 5.3 million people over 65 in the U.S., according to the National Alzheimer’s Association. By 2050 that number is expected to reach 11 million or more.
The disease is difficult to diagnose, particularly in its early stages when it resembles other cognitive problems. Currently, a definitive diagnosis is possible only after examining the brain tissue of deceased individuals. Tests for suspected Alzheimer’s are often expensive or invasive, and not every patient is able or willing to undergo them, the researchers stated.
A blood test would provide a convenient diagnostic method that could be performed by health care workers nearly anywhere. In addition, a definitive diagnosis is important because treatments specifically targeting Alzheimer’s might not be effective against other forms of neurodegenerative disease or cognitive decline, Dr. Díaz-Arrastia said.
Researchers associated with the Texas Alzheimer’s Research Consortium, a five-university group funded by the state, carried out the research. In the current study, the scientists analyzed blood samples from 197 Texas patients who had suspected Alzheimer’s and 203 people without the disease.
The researchers measured more than 100 blood proteins and created a mathematical analysis that could measure a person’s risk of having Alzheimer’s. The analysis, combined with information from a clinical exam, accurately detected Alzheimer’s 94 percent of the time, and correctly ruled out Alzheimer’s 84 percent of the time in people without the disease, Dr. Díaz-Arrastia said.
Neither the blood test nor a clinical exam alone was as accurate on its own as the blood test and clinical exam combined, the researchers found.
“Having a diagnosis is an important step, but it’s not the end of the road unless you’ve got a treatment or a cure,” Dr. Díaz-Arrastia said.
The next step in the work is to determine whether the biomarker test can detect accurately Alzheimer’s in preserved blood serum from patients who have been diagnosed definitively by an autopsy.
Other UT Southwestern researchers participating in the study were Dr. Guanghua Xiao, assistant professor of clinical sciences; Dr. Joan Reisch, professor of clinical sciences and family and community medicine; and Dr. Perrie Adams, professor of psychiatry.
Also participating were researchers from Texas Tech University Health Sciences Center, University of North Texas Health Science Center, Baylor College of Medicine, and Marshfield Clinic Research Foundation.
The study also was funded by the National Institutes of Health.
Visit http://www.utsouthwestern.org/neuro to learn more about UT Southwestern’s clinical services in the neurosciences, including memory disorders like Alzheimer’s disease.
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UPDATE:
AMORFIX ALZHEIMER’S TEST DETECTS AGGREGATED BETA AMYLOID IN HUMAN CSF
TORONTO, Ontario – January 7, 2011 – Amorfix Life Sciences, a product development company focused on diagnostics and therapeutics for misfolded protein diseases, today announced preliminary results indicating that their human Alzheimer’s disease (AD) diagnostic assay can detect a signal from aggregated beta amyloid in the spinal fluid (CSF) from AD patients. “These results represent a significant first step towards our goal of developing and commercializing an assay that will accurately identify patients with AD, a disease that currently affects more than 5 million people in North America, a number that is expected to grow dramatically as the population ages” said Dr. Robert Gundel, Amorfix President and Chief Executive Officer. “While there is still work to do, this represents an important milestone towards the development of a valuable asset for our company. A new diagnostic tool could enable the early detection and subsequent treatment of AD, while being a major adjunct to clinical research in the field.”
The sequence of events so far is that the Amorfix A4 test is the world’s first test (and at this point the only confirmed) that can detect Abeta in blood. On the 16 Sep 2010 the A4 test is validated by a scientific peer panel and published in a scientific journal. On the 21 Oct 2010, the company announced that they can detect abeta amyloids in brain tissue, CSF and blood of lab animals. In Nov 2010, the CEO verbally confirmed that the company has been able to detect the amyloids in dogs through CSF and Blood, but is not releasing the results as they want to use this platform to develop the CSF test for humans.
Early diagnosis and intervention will be key to managing the increase in Alzheimer’s and other forms of dementia. There are several paper-based tests that can provide a “first pass” screening for memory impairment: http://bit.ly/91Vb9K MyBrainTest.org
A Canadian Biotech company is just steps away from a blood test that will accurately detect Alzheimer’s. They are moving slowly, having every step scientifically confirmed. To giver you an idea how close they are, here is what has happened with the company these last 12 months. I think they are very close!
Press Releases
July 15, 2009 – Amorfix Life Sciences, a company focused on treatments and diagnostics for brain wasting diseases is presenting a paper today at the International Conference on Alzheimer’s Disease (ICAD2009) entitled “A4: An Ultrasensitive Method for the Detection of Aggregated β-Amyloid”. The hallmark of Alzheimer’s disease (AD) is the aggregation and accumulation of b-amyloid as plaques in the brain. The A4 assay can detect b-amyloid in standard animal models of AD several months before conventional microscopic procedures and hence can accelerate the preclinical screening of new drugs for AD. In addition, the assay is significantly more sensitive than current methods for detecting total Abeta and can be used in high-through-put applications designed to study the inhibition of amyloid formation.
May 4, 2010 – AMORFIX LIFE SCIENCES ANNOUNCES WORLD’S FIRST DETECTION OF AGGREGATED BETA-AMYLOID IN BLOOD USING THE ALZHEIMER’S DIAGNOSTIC A4 ASSAY..Amorfix Life Sciences, a company focused on treatments and diagnostics for misfolded protein diseases such as Alzheimer’s disease (AD), announced today the detection of the AD-associated aggregated Beta-amyloid (ABeta), the hallmark of AD, in the blood from the most-frequently-used animal model of AD. The assay detects both oligomeric and fibrillar aggregates of ABeta, which are generally considered to be the toxic forms and major contributors to brain dysfunction in AD.
July 6, 2010 – Amorfix Life Sciences Ltd. (TSX:AMF) and reMYND NV today announced the signing of a partnership agreement to offer the Amorfix A4 amyloid testing service to reMYND’s contract research clients. reMYND’s contract research business offers an extensive portfolio of preclinical in-vivo efficacy,pharmacokinetic and safety testing of experimental Alzheimer therapies using proprietary mouse models of Alzheimer’s disease (AD).
July 12, 2010 – Amorfix Life Sciences, a company focused on treatments and diagnostics for misfolded protein diseases including Alzheimer’s disease (AD), has used its A4 test to compare the rate of accumulation of aggregated Abeta in the brain tissue of various mouse models of AD. Amorfix presented this new data at the International Conference on Alzheimer’s Disease (ICAD 2010) this week.
September 16, 2010 – Amorfix Life Sciences, a company focused on treatments and diagnostics for misfolded protein diseases including Alzheimer’s disease (AD), is pleased to announce that data generated by its A4 test has been published in a peer-reviewed scientific publication. The Journal of Alzheimer’s Disease has published the research article entitled: Pathological Hallmarks, Clinical Parallels, and Value for Drug Testing in Alzheimer’s Disease of the APP[V717I] London Transgenic Mouse Model. In this paper, among other findings, the authors confirm the validity of the Amorfix A4 assay in detecting aggregated Abeta, which is a neuropathological marker of the “APP London” (APP-Ld) mouse model offered for preclinical in vivo drug testing by reMYND NV.
October 07, 2010 – Amorfix Life Sciences announced today that it has accepted an invitation to become a member of the Alzheimer’s Disease Neuroimaging Initiative (ADNI). The mission of ADNI is to establish and validate tests for brain images, as well as cerebral spinal fluid and blood biomarkers, as predictors of Alzheimer’s disease. Membership in ADNI will provide Amorfix access to leading research in the Alzheimer’s field and access to Human clinical samples necessary to validate the its A4 assay as a potential human diagnostic test.
October 21, 2010 Amorfix Life Sciences Ltd. (TSX:AMF) and Biotrofix, Inc. today announced that they have successfully detected the presence of the aggregated Beta-Amyloid (Abeta) peptide in the cerebral spinal fluid (CSF) from transgenic mice using the Amorfix A4 test. The results come from a collaborative study using the transgenic (Tg2576) mouse model of Alzheimer’s disease (AD). Following collection and analysis of CSF, plasma and brains from 3 month old transgenic and normal mice, they successfully detected the presence of the aggregated Abeta peptide in the CSF from the transgenic mice which correlated with the signal detected in the brains and plasma.
11-12 November 2010: Laguna Beach, CA, USA- Amorfix Life Sciences is attending the Canine Cognition, Aging and Neuropathology Conference